EDA - Regulatory Guide line For Central Administration For Biological , Innovation Products and clinical studies

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Guidline for Central administration of biological and innovative products and clinical studies

Type	Issue date	Content	Issue No.
Guideline	2022	لإجراءات المنظمة لتسجيل المستحضرات الحيوية بنظام الاعتماد Procedures for Registration of Biological products through Reliance pathways 2022	01
Guideline	2022	Good Review Practice Guideline	02
Guideline	2023	Guideline for Registration of Biosimilar Products in Egypt	04
Guideline	06/2023	الدليل التنظيمى لآليات تسجيل المستحضرات المبتكرة Regulatory Guideline of the Registration Procedures of the Innovative Products	01
Guideline	2023	ملحقات الدليل التنظيمى لآليات تسجيل المستحضرات المبتكرة Appendices of Regulatory Guideline of the Registration Procedures of the Innovative Product
-	2023	Appendices of Regulatory Guideline of the Registration Procedures of the Innovative Products	03
Guideline	04/2023	Guidelines on emergency use approval	04
Guideline	05/2024	Guideline on E-Labelling of Medical Leaflets of Medicinal Products for Human Use	02
Guideline	07/2024	Guideline for Post Market Quality Monitoring of Biological Products in Egypt	01
Guideline	09/2024	Guideline for Good Regulatory Oversight of Clinical Trials by Egyptian Drug Authority	03
Guideline	09/2024	Guideline for Lot Release of Biological Products in Egypt	02
Guideline	10/2024	Guideline for Preclinical testing and Clinical Investigation for Medical devices	01
Guideline	11/2024	Guideline for File Content of Biological Products for Registration & Re-registration file	04
Guideline	10/2025	الدليل التنظيمي لقواعد تطبيق قرار رئيس هيئة الدواء المصرية رقم /٣٤٣ ٢٠٢١ Regulatory Guideline of Mechanisms and Rules of Implementing the Decree of Egyptian Drug Authority's Chairman No. (343) of 2021	04
Guideline	12/2025	Guideline on the regulation of Post-approval changes to a registered Bio therapeutic products	02

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